safety and efficacy of abx-101 in participants aged 18 to 50 years of age with moderate to severe traumatic brain injury

Conditions: Traumatic Brain Injury; Cerebral Edema

Summary: the purpose of this study is to investigate the clinical improvement measured by the glasgow outcome scale extended (gos-e) with abx-101 compared with placebo intramuscular injection in participants with moderate to severe tbi.

study details include: * the study duration will be up to 180 days per participant. * the treatment duration will be up to 7 days. * the visits post-treatment will be on day 30 and day 180 of the study. number of participants: a maximum of 45 participants will be enrolled into the study and randomized to each treatment arm in a ratio of 1:1:1. i.e., fifteen participants per arm. study arms and duration: participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary tbi insult. enrolled participants will be stratified 1:1 (in each arm) by gcs score (gcs 4-8 in one group and gcs 9 - 12 in the other). the treatment period, which involves 6 hourly, i.e., quarter in die (qid), abx-101 (1 mg or 2 mg) intramuscular injections, is seven days. enrolled participant will continue with the in-hospital standard of care, as decided by the external treating physician, and will be followed up by the study team on days 30 and days 180. the abx-101 1 mg and 2 mg arm will be enrolled simultaneously.

Eligibility criteria:
inclusion criteria: * written informed consent from patient, patient's legal guardian or legal representative, or deferred consent procedure, according to local requirements * 18 - 50 years of age, inclusive * expected to survive more than 24 hours after admission * clearly defined time of injury no more than 12 hours before administration of study drug/placebo o subjects stratified 1:1 (in each arm) by treatment administered 0-12 hrs * tbi with glasgow coma score (gcs) 4-12 requiring intracranial pressure (icp) monitoring according to the assessment of the treating physician o subjects stratified 1:1 (in each arm) by gcs 4-8 and gcs 9-12 * catheter placement (intraventricular or intraparenchymal, only) for monitoring and management of increased icp * \[brain computed tomography (ct) showing intracranial parenchymal abnormality and hemodynamically stable\] exclusion criteria: * penetrating head injury (e.g. missile, stab wound) * concurrent, but not pre-existing, spinal cord injury * not expected to survive more than 24 hours after admission * pregnant, or a positive pregnancy test * coma due to an exclusive epidural hematoma (lucid interval and absence of structural brain damage on ct scan) * patient pupils are unresponsive (dilation) in both eyes * the subject has a neurodegenerative disease or other neurological disorder including dementia, parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors. * coma suspected to be primarily due to other causes than head injury (e.g. drug overdose intoxication, drowning/near drowning * known or ct scan evidence of pre-existing major cerebral damage * any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission * known to have received an experimental drug within 4 weeks prior to current injury * patients who cannot be monitored with regard to their recovery (gos-e and qolibri)

Keywords: traumatic brain injury